Ligence Heart

K252105

Ligence, UAB · cleared 2025-09-26 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters.”
Algorithmmachine-learning-based view classification, multiple image quality algorithms
source quote (p.5)
“Ligence Heart automatically identifies standard transthoracic echo views with machine-learning-based view classification, cardiac cycle selection, and border detection, then generates reproducible quantitative left-ventricular volumetric and functional measurements.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“A cybersecurity analysis and testing were conducted to verify that security measures are properly implemented in Ligence Heart to protect Ligence Heart's data, including patient health information (PHI).”

Validation studies (1)

Reader study (MRMC)

n=524 cases

endpoints: Individual Equivalence Coefficient (IEC); Intraclass Correlation Coefficients (ICC)

Reported performance (1 observation)

agreement_kappaas written: “Intraclass Correlation Coefficients (ICC)”stated without valueCI ≥ 0.90
source quote (p.9)
“Intraclass Correlation Coefficients (ICC) were ≥ 0.90 for all four parameters.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253535 (decision 2026-02-27) from Ligence Uab for a matching device line ("Ligence Heart") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253535

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252105